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Note: The U.S. Supreme Court has made a practice lately of slapping down the U.S. Court of Appeals for the Federal Circuit, the court Congress has designated for hearing appeals of patent cases. In this guest post about a decision involving the famous clone Dolly the Sheep, the authors explain how the Federal Circuit may have finally gotten the message about broad and overly protective patents. But by leaving open the possibility of patenting other clones, the court may have left itself open to yet another dressing-down by the Supremes -- Daniel Fisher

Taking its place in a long line of decisions examining the patentability of naturally occurring organisms, on May 8, 2014, the Federal Circuit released its latest precedential opinion starring Dolly the Sheep—In re Roslin Institute (Edinburgh). The tale began in 1996 when Dolly the Sheep became the first mammal ever cloned from an adult somatic cell through the successful work of Keith Henry Stockman Campbell and Ian Wilmut.[1] Campbell and Wilmut patented their breakthrough method of cloning mammals using somatic cells.[2] In addition, they applied for a patent claiming the actual cloned animals themselves—U.S. Patent Application No. 09/225,233 (the ’233 application).[3]

Specifically, the claims of the ’233 application were directed towards the live-born clones of “cattle, sheep, pigs, and goats.”[4] Whether these claims constituted patent eligible subject matter was the focus of the Federal Circuit’s opinion in Roslin. The case reached the Federal Circuit after the patent examiner rejected the claims of the ’233 application as directed to patent ineligible subject matter under 35 U.S.C. § 101, and the Patent Trial and Appeal Board affirmed.[5]

Too close to the original to be patented. (Photo credit: Wikipedia)

Briefly citing the recent Supreme Court decision in Myriad, where the Court held that isolated BRCA genes were products of nature not eligible for patent protection,[6] the Federal Circuit went on to review the Supreme Court’s longstanding decisions regarding naturally occurring organisms in Chakrabarty and Funk Bros.[7] In Funk Bros. the Court held that a naturally occurring mixture of bacteria that helped plants extract nitrogen from the environment were not patent eligible because the patentee did not add to or alter the naturally occurring bacteria in any way.[8] Clarifying the scope of Funk Bros., the Court in Chakrabarty held that an engineered bacterium that was capable of breaking down components of crude oil was patent eligible because it contained “markedly different characteristics from any found in nature.”[9]

In Roslin, the Federal Circuit attempted to clarify the scope of these Supreme Court decisions determining the patent eligibility for naturally occurring organisms. Contrasting the Supreme Court’s decisions in Chakrabarty and Funk Bros., the Federal Circuit noted that Dolly was an exact genetic replica of the parent used to clone her, containing no markedly different characteristics.[10] Instead, as in Myriad, the Federal Circuit emphasized that the patentee did not alter any naturally occurring genetic material to create Dolly.[11] In its decision, the Federal Circuit emphasized that Dolly was an exact genetic copy of patent ineligible subject matter.[12]

The Federal Circuit rejected Roslin’s arguments that differences in phenotypic variation and mitochondrial DNA rendered the subject matter patent eligible, noting that those differences were unclaimed.[13] Moreover, the Federal Circuit emphasized that the phenotypic variations observed in Dolly were merely the result of environmental factors; further, the Federal Circuit noted that Dolly’s mitochondrial DNA was not markedly different because it came from the oocyte used to create her.[14] Notably, the Federal Circuit stated expressly that its decision did not foreclose the possibility that a clone with the same DNA could be patent eligible.[15] Instead, it held that in a scenario where there are no markedly different characteristics between the clone and its donor, the claimed subject matter is not patent eligible.[16]

Roslin solidified the scope of what has been the growing trend in § 101 law—products of natural phenomenon that contain no (or at the least fail to claim any) markedly different characteristics are not patent eligible subject matter. Some practitioners have criticized Roslin as an unnecessary, risky § 101 decision that provided no new guidance, and will only once again gain the attention of the Supreme Court[17]—a Court that has been ever so consistently pushing back on the Federal Circuit’s decisions regarding § 101. Perhaps, however, Roslin represents an attempt by the Federal Circuit to further clarify the law on a controversial subject in an effort to meld its precedent with the admonitions of the Supreme Court. Tellingly, rather than paving a new esoteric path of case law, the opinion relies heavily on the long line of Supreme Court precedent before it.